On November 11, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported new preclinical data on JTX-8064, the first tumor-associated macrophage program from their Translational Science Platform, at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Annual Meeting (Press release, Jounce Therapeutics, NOV 11, 2020, View Source [SID1234570563]). The poster presentation includes preclinical human histoculture data highlighting Jounce’s approach to identifying potential predictive and pharmacodynamic (PD) markers of response to JTX-8064 that may identify patients more likely to benefit from JTX-8064 monotherapy or in combination with PD-1 inhibitors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The JTX-8064 poster at SITC (Free SITC Whitepaper) showcases the strength of our Translational Science Platform for identification of targets and potential predictive and PD biomarkers to inform indication selection in our first clinical trial," said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. "The mechanism of action of JTX-8064 coupled with this histoculture data suggests the potential to address PD1 inhibitor resistant tumors. The data presented at SITC (Free SITC Whitepaper) supports the exploration of potential predictive biomarkers to identify patients more likely to benefit from JTX-8064 alone or in combination with a PD-1 inhibitor. We will be including retrospective assessment of potential predictive biomarkers in the first in human clinical trial, for which we expect to commence enrollment by the end of the year."

In a poster titled "Evaluating Biomarkers of JTX-8064 (anti-LILRB2/ILT4 monoclonal antibody) in an Ex Vivo Human Tumor Histoculture System to Inform Clinical Development," Jounce researchers highlighted:

PD responses to JTX-8064 can be measured preclinically in an ex vivo human tumor histoculture system
Baseline LILRB2, classical MHC I molecules and macrophage markers predict PD response to JTX-8064 in histoculture samples and will be an important component of indication selection in the clinic
Some tumor samples that do not have a PD response to either JTX-8064 or anti-PD-1 antibodies alone respond to the combination of both agents, suggesting that JTX-8064-mediated LILRB2 inhibition could be a critical component in rescuing responsiveness
Ex vivo evaluation of human tumors identified hypotheses for both predictive and PD markers that can be evaluated in the clinical development of JTX-8064
The poster is available on the "Our Pipeline" section of the Jounce Therapeutics website at www.jouncetx.com.

About JTX-8064
JTX-8064 is a humanized anti-LILRB2 (ILT4) antibody and is the first tumor-associated macrophage candidate to emerge from Jounce’s Translational Science Platform. In addition to today’s SITC (Free SITC Whitepaper) poster presentation, preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supports the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity. A Phase 1 clinical trial for JTX-8064 as a monotherapy and in combination with a PD-1 inhibitor is planned for 2020.

On November 10, 2020 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body, reported it will host a conference call and webcast to provide a business update on Tuesday, November 17, 2020 at 4:30 p.m. EST (Press release, Cue Biopharma, NOV 10, 2020, View Source [SID1234608291]). Live and archived versions of the event can be accessed via the Company’s website.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Members of the Cue Biopharma executive management team will provide a clinical update including details pertaining to patients from cohorts 4, 5 and 6 in the Company’s ongoing Phase 1 monotherapy dose escalation clinical trial of CUE-101 for the treatment of HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Management will also provide an update on the Company’s technology platforms and pipeline progress, as well as updates on its strategic objectives and anticipated milestones.

Tuesday, November 17 at 4:30 p.m. EST

Investors:
International:
Conference ID:
Webcast: 877-407-9208
201-493-6784
13712195
View Source

On November 10, 2020 Aravive Inc., a clinical-stage oncology company developing transformative therapeutics, and 3D Medicines Inc., a China-based biopharmaceutical company developing next-generation immuno-oncology drugs, reported a collaboration and exclusive license agreement for the development and commercialization of AVB-500 across all oncology indications in mainland China, Hong Kong, Macau, and Taiwan (Greater China) (Press release, 3D Medicines, NOV 10, 2020, View Source [SID1234594023]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AVB-500 is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and is also evaluating AVB-500 in clear cell renal cell carcinoma.

"We believe 3D Medicines is an excellent partner for the development and potential commercialization of AVB-500 in China," said Gail McIntyre, Ph.D., Chief Executive Officer of Aravive. "3D Medicines has built a pipeline with both innovative biological and small-molecule anti-tumor drugs and a professional team with global development, registration and commercialization capabilities. Following promising results from our Phase 1b trial of AVB-500 in platinum resistant ovarian cancer, we are excited to partner with 3D Medicines to potentially bring AVB-500 to patients in China, expanding AVB-500 clinical indications and broadening our geographic reach."

Under the terms of the agreement, Aravive will receive a signing payment of $12 million and be eligible to receive up to $207 million in development and commercial milestone payments with the potential for near term milestone payments of $6 million. In addition, 3D Medicines will pay Aravive tiered royalties ranging from the low double digits to mid-teens as a percentage of annual net sales of AVB-500 in Greater China. 3D Medicines will be responsible for all costs associated with development and commercialization activities for AVB-500 in Greater China. Aravive will retain all rights to AVB-500 in the rest of the world and will continue to be responsible for the development and commercialization of AVB-500 in the United States and other geographies.

"We are very pleased to enter into this exclusive collaboration with Aravive," said John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines. "We believe that AVB-500, used in combination with existing standard of care therapeutics or Envafolimab, an innovative subcutaneous PD-L1 antibody to be launched in China soon, could alter the treatment paradigm across various tumor types. We are committed to working closely with Aravive to further advance the development of AVB-500 and bring this important potential therapy to patients living with cancer in China."

BFC Group, Ltd. acted as advisors to Aravive, Inc.

About AVB-500
AVB-500 is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, AVB-500 selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. AVB-500 is currently being evaluated in clinical trials and has been granted Fast Track Designation by the U.S. Food and Drug Administration in platinum resistant recurrent ovarian cancer. Analysis of all safety data to date showed that AVB-500 has been generally well-tolerated with no dose-limiting toxicities or unexpected safety signals.

On November 10, 2020 ValiRx (AIM: VAL) a clinical stage drug development company, reported that it has entered into an agreement with Kalos Therapeutics (Kalos), a US-based private biotechnology company, to evaluate its peptide KTH222 as a drug candidate for treating patients with ovarian cancer. This project underscores ValiRx’s new strategy to grow a pipeline of innovative, early-stage projects in the area of oncology and women’s health (Press release, ValiRx, NOV 10, 2020, View Source [SID1234573535]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, ValiRx has the right to perform a defined series of preclinical, cell-based assays to consider the benefit of using KTH222 in combination with standard of care treatment, Paclitaxel. At the conclusion of the estimated six-month evaluation schedule (May 2021), ValiRx has the option to enter a full licensing agreement, with KTH222 anticipated to be integrated into a jointly owned ValiRx subsidiary for further clinical development.

Kalos has completed lead optimisation and proof-of-concept preclinical studies. Kalos will remain actively interested in the programme, contributing scientific expertise during the evaluation period and is expected to be an active partner in the subsequent joint venture. In return, on entering the evaluation agreement, Kalos has been pledged 10,000 ValiRx shares, subject to approval by shareholders at the 2021 Annual General Meeting of the Company.

Dr Suzy Dilly, CEO of ValiRx commented, "I am delighted to announce this new evaluation agreement with Kalos Therapeutics. This project is an excellent example of the assets we are looking to acquire; ovarian cancer sits squarely in our portfolio focused on oncology and women’s health, and the peptide nature of the drug is within our development expertise. Importantly, this agreement underscores our new strategy to identify and develop promising early-stage therapies with the aim of progressing such assets to the next stage of development."

George Colberg, CEO of Kalos Therapeutics added, "I’m looking forward to working with the ValiRx team to further our development of KTH222 into ovarian cancer. Our central ethos at Kalos has always been to develop drugs that are kinder to patients, and we were delighted to find a team with comparable ideals."

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!